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Clinical Trial With Local Decitabine Treatment of HPV-Induced VIN Grade 2/3 (DelVIN)

NCT05717621 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-02-11

No results posted yet for this study

Summary

This is a multicentre open labelled phase I trial evaluating the safety and preliminary efficacy of local decitabine treatment of human papillomavirus (HPV)-induced vulvar intraepithelial neoplasia (VIN) grade 2/3.

The main purpose and primary objective of the study is to determine the recommended phase 2 dose (RP2D) of VTD-101 ointment for the topical treatment of HPV-induced VIN grade 2/3. The RP2D is defined as the dose that is safe, tolerable and effective. Corresponding endpoints are the rate of patients experiencing at least one dose limiting toxicity (DLT) and the rate of patients with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria.

Secondary objectives are to further characterize the efficacy of topical treatment with VTD-101 ointment, to further evaluate the safety and tolerability of topical treatment with VTD-101 ointment, and to evaluate quality of life (QoL) in patients treated with VTD-101 ointment.

Conditions

  • Vulvar Intraepithelial Neoplasia Grade 2
  • Vulvar Intraepithelial Neoplasia Grade 3

Interventions

DRUG

VTD-101 ointment

Self-administration of VTD-101 ointment (Decitabine ointment)

Sponsors & Collaborators

  • Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest

    collaborator UNKNOWN

  • ViMREX GmbH

    lead INDUSTRY

Principal Investigators

  • Elena-Sophie Prigge, Dr. · ViMREX GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2025-01-17
Completion
2025-01-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717621 on ClinicalTrials.gov